Characterization of products formed by forced degradation of Etodoalc using LC/MS/MS

Forced degradation is a process, whereby the natural degradation rate of a drug product or drug substance is accelerated by the application of an additional stress. Understanding of these products qualitatively and at times quantitatively, can assist in predicting their toxicity and in deciding shelf life of the drug. The ICH guidelines indicate that stress testing is designed to determine the stability of the molecule by knowing degradation pathways in order to identify the likely degradation products. The degradation products are those formed under different stress conditions such as temperature, humidity, oxidation, photolysis and susceptibility to hydrolysis across a wide range of pH value.